MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES

Model Number	8900-0221-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn.The customer was unable to provide information on the degree of the burn.Please reference medwatch report 1218058-2021-00072 for a similar event reported from the same customer.
Additional Manufacturer Narrative
The one-step electrode pads and associated device were returned to zoll medical corporation.The customer's report was not replicated or confirmed.Review of the device history log shows that all shocks on the event date were found to be within specification.There was no evidence of any impedance or coupling issues found.The pads were evaluated with no discrepancies found.There is some evidence that there may have been air trapped beneath the pads, however, this cannot be confirmed.No photos of the reported burns were provided.Without both sets of pads or photos of the burns, the report cannot be refuted or confirmed.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11826710
• Report Number: 1218058-2021-00071
• Device Sequence Number: 3610728
• Product Code: MKJ
• UDI-Device Identifier: 00847946016241
• UDI-Public: 00847946016241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 02/19/2023
• Device Model Number: 8900-0221-01
• Device Catalogue Number: 8900-0221-01
• Device Lot Number: 0821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other